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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04290949
Other study ID # Platelet indices in acute MI
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 20, 2020
Est. completion date December 1, 2021

Study information

Verified date February 2020
Source Assiut University
Contact Ishraq Hassan, Physician
Phone +201065967424
Email Ishraqhosny@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To assess the platelet indices in patients undergoing primary percutaneous coronary intervention and its relation to the severity of coronary artery disease and short term clinical outcomes


Description:

Acute coronary syndromes (ACS) is a type of acute coronary artery disease (CAD), It is a highly prevalent group of emergency diseases, associated with high morbidity and mortality (1)

ACS include ST- elevation Myocardial Infarction (STEMI), non ST-Elevation Myocardial Infarction (NSTEMI) and Unstable Angina (UA) (2).

ACS characterized by plaque rupture and acute thrombosis formation in the coronary arteries (3)

platelet morphology and function have vital roles in the pathogenesis of many diseases related to coagulation, thrombosis, inflammation, and endothelial dysfunction (4)

Platelets play a crucial role in thrombotic episodes, its activation is acritical factor in the creation and evolution of atherothrombosis. (5)

Not only platelets are essential for the thrombotic vascular occlusion at the ruptured atherosclerotic plaque but also they contribute to the obstruction and impairment of coronary micro circulation (6).

Risk stratification plays a crucial role in the management of patients with ACS (7).

Patients estimated to be at higher risk may be managed with earlier and more aggressive treatment, whereas those with lower risk may be managed with less intensive treatment (8).

Many biomarkers have been evaluated, and various scores have been created for risk stratification of ACS patients (9)

Mean platelet volume (MPV) has been proposed as a primary marker for platelet activation, as larger sized platelets have been associated with higher pro-thrombotic risk, and its measurement is easy and time effective (10-14)

- So It may elevate in patients with ACS and its role, It could be a useful bio marker of risk of stratification (15)

- Platelet Distribution Width (PDW) measured on admission is a cheap and generally available biomarker which allows for predicting the development of heart failure in patients with ACS after PCI (16)

showed that an increased level of PDW was related to the severity of CAD in patients with ACS (17).

Numerous studies support the association of Mean platelet volume (MPV) with adverse cardiac outcomes as restenosis stent thrombosis in patients with ACS (19-24) al.2011


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 1, 2021
Est. primary completion date October 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Adult patients (age = 18 years) that presented with acute ST elevation myocardial infarction

Exclusion Criteria:

1. Cardiomyopathy,

2. Previous revascularization procedure

3. Any history of bleeding diathesis

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary the severity of coronary artery disease and short term clinical outcomes Platelet indices as mean Platelet Volume (MPV)in femtoliter , platelet distribution width (PDW) (FL)% and (PCT)% May be larger and could be a risk of Stratification in patients undergoing primary percutaneous coronary intervention follow up patients 6 monthes
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